A process of method development: A chromatographic approach

Introduction  

Prior to the initiation of method development, all the known information about the analyte such as its structure, physical and chemical properties, toxicity, purity, hygroscopicity, solubility, and stability should be determined. These data may be available from preformulation reports, early drug discovery sample screening reports, from the literature on similar compounds, or from past experience with similar compounds. However, many times this information is not available, so preventive measures must be taken in order to ensure that the analyte does not degrade or change during the method development scouting experiments. Implementation of a tray cooler, preparation of fresh samples, storage of samples in a refrigerator, and protection of the solids and sample solutions from light represent some common preventive measures.